Informed consent materials for a clinical trial

Informed consent materials are the documents that carry consent in a clinical trial: the consent form, the participant information sheet and the materials given beside them. The parts divide by what a writer has to settle about them: what the rules require of their content and of the consent process, why they fail their readers, how the writing brings them within a reader's reach, how they are tested, how particular settings change them, and how they are kept up across the trial and supported by an institution. What a child signs and reads is left to assent forms and information materials for young participants, how ethics committees review research to research ethics and ethics review, the device investigation's own plan to clinical investigation plans, and readability measures in general to readability and testing with readers.

• What informed consent materials must explain — the two parts of a consent form, the elements ICH E6(R3) and US federal regulation require, the twenty elements multinational forms share, what national authorities add, and exculpatory language
• The consent process ICH E6(R3) requires — the conditions consent has to meet, the signature and the copy, representatives, witnesses and emergency enrolment, re-consent when the evidence or the conduct of the trial changes, withdrawal and the data it leaves behind, and consent for real-world data
• Why consent forms fail the people who read them — who the reader is, the evidence that forms are too hard to read, why forms keep growing longer, and what translation adds
• Making consent information a participant can decide from — what the decision needs, the limits of understanding, a lean, layered document, plain wording in the participant's own language, formats beyond text, and a fair balance of benefit and risk
• Writing a consent form at the reading level participants need — the grade-level targets, the readability measures for checking a draft, and plain, conversational rewrites of research language at that level
• Writing the side-effects section of a consent form — selecting the side effects to list and combining similar ones, wording each entry for a lay reader, ordering them by likelihood and body system, and the standing preamble
• Designing consent materials visually — a consent form laid out with white space and icons, a readable visit schedule, a figure for a complicated treatment schedule, icons revised for what they could be taken to mean, and visual aids in the consent discussion
• Testing consent materials with readers before the trial uses them — user testing against find-and-understand targets, review by patients and patient advocates, and the one-reader check
• The participant information sheet a UK ethics committee will pass — the faults a UK research ethics committee keeps finding, what it checks in every participant-facing document, the Health Research Authority's guidance and quality standards, the six things the committee always wants explained, and the sheet's simplicity, length, wording for the country, balance of benefit and risk, and separate versions for different participants
• Consent in special circumstances — emergency enrolment without prior consent, consent taken at a distance, and the argument that consent is eroding
• Patient information and informed consent for device investigations — the rules a device study's participant materials answer to, the content list, the consent page and its handwritten entries, withdrawal from an implant study, extended follow-up and further use of the data, vulnerable subjects, the master document and its local versions, keeping it short enough to be read, the ethics committee's first response, and model forms to draw ideas from
• Participant materials as education across the trial — the case for investing in participant education, the ethics review every update goes through, and education at recruitment, at consent and throughout the study
• An institutional editing service for consent documents — editors inside the review loop, a library of approved lay language and lay terms for side effects, the one-page overview, the templates, consistency across the institution's documents, and keeping these resources accurate